"The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug"...
NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- Do not administer OptiMARK to patients with:
- chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
- acute kidney injury [see CONTRAINDICATIONS].
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- Do not exceed the recommended OptiMARK dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see WARNINGS AND PRECAUTIONS].
OptiMARK (gadoversetamide) injection is a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for intravenous injection.
OptiMARK injection is provided as a sterile, preservative-free, nonpyrogenic, clear, and colorless to pale yellow, aqueous solution of gadoversetamide. Each mL of OptiMARK contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.
Gadoversetamide is designated chemically as [8, 11-bis(carboxymethyl)-14-[2-[(2-methoxyethyl)amino]-2-oxoethyl ]-6-oxo-2-oxa-5, 8,1 1, 14-tetraazahexadec an-16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and empirical formula of C20H34N5O10Gd. The structural formula of gadoversetamide in aqueous solution is:
OptiMARK has a pH of 5.5 to 7.5. Pertinent physiochemical data are provided below (Table 4).
Table 4 : Physiochemical Properties of OptiMARK
|Osmolality (mOsmol/kg water) @ 37°C||1110|
|Viscosity (cP) @ 20°C||3.1|
|Density (g/mL) @ 25°C||1.160|
OptiMARK has an osmolality of approximately 3.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use.
What are the possible side effects of gadoversetamide (OptiMARK)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite;
- swelling, weight gain, feeling short of breath; or
- fast, uneven heart rate.
Less serious side effects may include:
- headache, dizziness;
- nausea, diarrhea;
Last reviewed on RxList: 12/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional OptiMARK Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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